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Angela McCauley
Life Science

+353 87 696 0951
[email protected]
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Details

Validation Engineer - Isolator Equipment


Reference:AMC23440 Location: Carlow
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Validation Engineer

11 month contract
Validation Engineer - Isolator
On site Carlow
AMC23440

We are currently hiring for a Validation Engineer role with a rapidly expanding biopharmaceutical manufacturer based in Carlow. In this role you will support Isolator Airflow Visualisation/ VHP/HVAC Qualification.

The ideal candidate will have 3+ years of experience in validation of sterile fill finish processes and equipment and a relevant degree

In order to excel in this role, you will more than likely have:

  • Experience in authoring, reviewing, executing and approving Isolator Airflow Visualisation/ VHP/HVAC Qualification documents.
  • Considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills:
  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
  • Exception / Deviation Management and Change Control.
  • Demonstratable experience of leading technical related projects.
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable
  • Equipment and process validation.
  • Sterile Fill-Finish processes and equipment.
Knowledge and experience of the below areas will be considered advantageous.
  • Filter Validation
  • CCI qualification
  • Shipping Qualification
  • Equipment Periodic Validation
  • Equipment Validation Lifecycle
  • Project Management Skills/Qualification
  • Autoclave/SIP Sterilisation Validation
  • Dry Heat Sterilisation
  • Cleaning Validation
  • Controlled Temperature Units/Equipment Qualification
  • Vial and Syringe Processing Technologies

Get in touch with Angela McCauley at Life Science Recruitment or apply today